Hanmi Pharmaceutical Targets Mexico for Global Launch of Novel Obesity Drug
South Korean pharmaceutical firm Hanmi Pharmaceutical is strategically positioning Mexico as the launchpad for its innovative obesity treatment, efpeglenatide, capitalizing on a faster commercialization pathway and a favorable market environment.
Hanmi Pharmaceutical is bypassing the complex regulatory hurdles and reimbursement processes common in markets like Korea to accelerate the global rollout of its new drug. The company recently signed an exclusive distribution agreement with Mexican pharmaceutical giant Sanfer (Laboratorios Sanfer) for efpeglenatide, alongside its established diabetes treatment, the Daparon Family.
This partnership signifies more than a simple export deal; it represents a test case for a novel sales model combining finished product supply with localized distribution. According to industry sources, Hanmi anticipates leveraging the results from the Mexican market to refine a broader global sales strategy focused on increased accessibility.
Sanfer, established in 1941, is Mexico’s largest private pharmaceutical company, boasting a robust sales and distribution network spanning Central and South America, as well as its own research and development capabilities. The company’s recent acquisition of biopharmaceutical firm Probiomed further solidifies its position as a leading player in the region, creating significant synergy with Hanmi’s ambitions.
Mexico presents a compelling market opportunity due to its high prevalence of both obesity (36.8%) and diabetes (16.4%). The substantial demand for blood sugar management, particularly in conjunction with weight loss and maintenance, underscores the strategic value of efpeglenatide. Interim results from a Phase 3 clinical trial in Korea demonstrated an average weight loss rate of approximately 9.75% in the medication group at week 40, a statistically significant difference compared to the placebo group, based on a study of 448 adult obese patients.
A key driver behind this strategic move is the streamlined commercialization process in Mexico. Unlike Korea, where securing reimbursement and setting drug prices for obesity treatments can be protracted, Mexico offers a relatively swift path to market through partnerships with local distributors. “In the case of GLP-1 type obesity drugs, the reimbursement, price, and prescription range are strict even after approval in Korea,” a senior official stated. “Mexico has many cases where the approval strategy is relatively flexible through a combination of ‘local clinical trials’ and ‘overseas data.’”
The accessibility-focused approach contrasts with the premium GLP-1 market dominated by Novo Nordisk and Lilly, which relies heavily on insurance coverage and direct engagement with healthcare systems in the US and Europe. Hanmi’s strategy prioritizes distribution and accessibility, sharing commercialization risk with local partners like Sanfer and expanding reach. The potential for expansion beyond Mexico, leveraging Sanfer’s network throughout Central and South America, is also being actively considered.
Hanmi Pharmaceutical is also preparing to broaden its portfolio with a “metabolic disease package,” integrating efpeglenatide with its existing diabetes treatments. The company recently completed its application for efpeglenatide approval with the Korean Ministry of Food and Drug Safety and received approval for a Phase 3 clinical trial combining efpeglenatide with SGLT-2 inhibitors and metformin. The goal is to secure approval for obesity treatment in the latter half of this year and add diabetes indications by 2028.
“Starting with the launch in Mexico, the scenario is likely to sequentially expand from markets with relatively low reimbursement and approval burdens, such as Central and South America,” another official noted. “This is a stepping stone to expand the position of Korean-style obesity treatments with a ‘selective globalization’ strategy that puts accessibility and speed of commercialization first.”
The development of efpeglenatide has a unique history. Originally licensed to Sanofi in 2015, the rights were returned to Hanmi in 2020 when Sanofi adjusted its metabolic disease strategy. Hanmi subsequently refocused the drug’s development on obesity indications. This expansion into Mexico marks the first instance of Hanmi independently pursuing commercialization without relying on a global pharmaceutical giant, potentially informed by the lessons learned from the previous technology transfer experience. This strategic shift underscores a commitment to a new global sales model centered on finished product export and local distribution partnerships.
